Ph2 Nab-paclitaxel With Gemcitabine to Determine Efficacy in Advanced Non-squamous NSCLC.

October 31, 2017 updated by: West Virginia University

A Phase II Randomized Study of Nab-paclitaxel With Gemcitabine at Two Different Dose Combinations to Determine Efficacy in Patients With Advanced Non- Squamous Non-small Cell Lung Cancer (NSCLC).

Phase II study to determine progression free survival (PFS) of nab-paclitaxel administered in combination with gemcitabine, at two different dose combinations as first line therapy in patients with unresectable stage IIIB/stage IV non-squamous non-small cell lung cancer (NSCLC).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This study is designed determine progression free survival (PFS) of nab-paclitaxel administered in combination with gemcitabine at two different dose combinations in patients with unresectable stage IIIB/stage IV non-squamous non-small cell lung cancer (NSCLC). Two dosing strategies of the nab-paclitaxel plus gemcitabine combination will be compared for efficacy and tolerability. One arm will combine both agents at their current Food and Drug Administration (FDA) approved doses for the indication of non-small cell lung cancer (NSCLC). This arm will utilize gemcitabine 1250 mg/m2 IV day 1 and day 8 (FDA approved dose in combination with cisplatin) combined with nab-paclitaxel 100 mg/m2 IV day 1, 8 and 15 every 21 days (FDA approved dose in combination with carboplatin). The second arm will utilize the drugs at doses that are approved by the FDA when combined with one another in metastatic pancreatic adenocarcinoma. This arm will consist of gemcitabine 1000 mg/m2 IV day 1, 8 and 15 combined with nab-paclitaxel at 125 mg/m2 IV day 1, 8 and 15 every 28 days. Patients will be randomized equally to the two treatment arms. Primary objective is to assess progression-free survival (PFS). Toxicity assessment, response and overall survival are secondary endpoints. Statistical power is based on the comparison to historical control within each treatment arm. In particular, a sample size of 23 patients in each arm will have 84% power to differentiate the 3-month PFS of 30% (null hypothesis) versus 60% (alternative) based on a 2-sided test at a significance level of 0.05. There will be a lead-in phase to this trial for each treatment arm with a cohort size of 3 and a maximum of 6 patients.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Hospitals - Mary Babb Randolph Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with histologically proven newly diagnosed stage IV or stage IIIB non-squamous Non-small Cell Lung Cancer (NSCLC) - Recurrent advanced NSCLC will be allowed if they have never received chemotherapy for metastatic disease. - Prior adjuvant chemotherapy will be allowed, if recurrence occurred ≥ 6 months after last treatment
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  • Washout period of 4 weeks for chemo/radiation/experimental agents
  • Resolution of all toxicities to < grade 2 prior to starting treatment (excluding alopecia)
  • Patients must have < Grade 2 pre-existing peripheral neuropathy (per CTCAE)
  • Adequate hepatic, renal, and bone marrow functions
  • Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment
  • Negative serum or urine β-hCG pregnancy test at screening for patients of childbearing potential

Exclusion Criteria:

  • Patient with New York Heart Association class III or IV heart failure
  • Women of child bearing potential (WOCBP) are not currently pregnant or breast-feeding
  • Co-existing malignancy or malignancies diagnosed within the last 3 years with the exception of basal cell carcinoma
  • Previous anaphylactic or severe allergic reaction to paclitaxel and/or docetaxel will be excluded
  • Grade ≥2 peripheral neuropathy at baseline assessment from any cause
  • Symptomatic brain metastases will be excluded. Treated Brain metastases will be allowed that are neurologically stable.
  • Patients with adenocarcinoma with activating EGFR mutation (exon 19 deletions / insertions, exon 21 point mutations) or EML4-ALK translocation are excluded unless they are ineligible for epidermal growth factor receptor (EGFR) or ALK targeting agents.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A - Nab-paclitaxel 100mg + Gemcitabine 1250mg
Nab-paclitaxel 100 mg/m2 as a 30 minute infusion (maximum infusion time not to exceed 40 minutes) on days 1, 8 and 15 of a 21 day cycle. On days 1 and 8 of each cycle, nab-paclitaxel administration will be followed by the administration of gemcitabine 1250 mg/m2 as a 30 minute infusion (maximum 40 minutes).
Drug: Gemcitabine
Other Names:
  • Gemzar
  • LY-188011
Drug: Nab-paclitaxel
Other Names:
  • ABI-007
  • Abraxane
Experimental: B - Nab-paclitaxel 125mg + Gemcitabine 1000mg
Nab-paclitaxel 125 mg/m2 as a 30 minute infusion (maximum infusion time not to exceed 40 minutes) on days 1, 8 and 15 of a 28 day cycle. Each nab-paclitaxel administration will be followed by the administration of gemcitabine 1000 mg/m2 as a 30 minute infusion (maximum 40 minutes) on days 1, 8 and 15. Treatments will be repeated until progression or intolerance.
Drug: Gemcitabine
Other Names:
  • Gemzar
  • LY-188011
Drug: Nab-paclitaxel
Other Names:
  • ABI-007
  • Abraxane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: From date of first treatment until the date of first documented progression or date of death, which ever occurs first, assessed up to 60 months.
To assess the progression-free survival (PFS) on patients with nab-paclitaxel and Gemcitabine at two different dose combinations and to compare the PFS to the historical data
From date of first treatment until the date of first documented progression or date of death, which ever occurs first, assessed up to 60 months.

Secondary Outcome Measures

Outcome Measure
Time Frame
To explore differences in progression free survival (PFS) between two dose combinations of nab-paclitaxel with Gemcitabine in patients with advanced NSCLC.
Time Frame: From date of first treatment until the date of first documented progression or date of death, which ever occurs first, assessed up to 60 months.
From date of first treatment until the date of first documented progression or date of death, which ever occurs first, assessed up to 60 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West Virginia University

Collaborators

Celgene Corporation

Investigators

  • Principal Investigator: Manish Monga, MD, West Virginia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 15, 2015

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

March 24, 2015

First Submitted That Met QC Criteria

March 27, 2015

First Posted (Estimate)

April 1, 2015

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

October 31, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WVU020514

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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